MAUDE Adverse Event Report: MEDTRONIC HEART VALVES, INC. MELODY TRANSCATHER PULMONARY; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB1018

Device Problem Occlusion Within Device (1423)

Patient Problems Regurgitation (2259); Stenosis (2263)

Event Date 04/09/2014

Event Type  Injury  

Event Description

Medtronic received information that approximately six years following the implant of this transcatheter pulmonary valve (tpv), another manufacturer¿s valve was implanted within this device due to stenosis and central regurgitation.This tpv initially was implanted within another tpv due to stent fractures.A stenting of this valve was performed; however, the result of the stenting was inconclusive and the physician concluded that the scaffolding of the stenosed area was not strong enough to support a third valve of this type.No subsequent adverse patient effects were reported.

Event Description

Subsequently, the facility that performed the valve replacement procedure indicated that they did not have the serial number of the previous device implants as they were performed at another facility.

Manufacturer Narrative

The product remains implanted and therefore has not been returned to medtronic.Without the serial number of the product no device history could be pulled and reviewed.Additional information has been requested.A supplemental report will be filed when the investigation is completed.(b)(4).

Manufacturer Narrative

Without the serial number a device history record review could not be performed.A conclusive root cause to this valve¿s stent fracture was not determined.Based on clinical data and literature, stent fractures are a known phenomenon and prominent mechanical stresses on the outflow tract stent appear to be associated with an increased risk of stent fracture.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHER PULMONARY
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES, INC.; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3790684
• MDR Text Key: 4433023
• Report Number: 2025587-2014-00264
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H080002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention